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tramadol/acetaminophen (Rx)Brand and Other Names:Ultracet

 
 
 

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

tramadol/acetaminophen

tablet: Schedule IV

  • 37.5mg/325mg
more...

Acute, Short-Term Pain

2 tablets PO q4-6hr PRN; not to exceed 8 tablets/day

Treatment duration: 5 days or less

Dosage Modifications

Renal impairment: If CrCl <30 mL/min, 2 tablets PO q12hr; treatment duration should not exceed 5 days

Hepatic impairment: Do not administer

Healthcare professionals can direct patients to take 1 or 2 tablets, capsules, or other dosage units of a prescription product containing 325 mg of acetaminophen up to 6 times daily (12 dosage units) and still not exceed the maximum daily dose of acetaminophen (ie, 4000 mg/day)

Dosage Forms & Strengths

tramadol/acetaminophen

tablet: Schedule IV

  • 37.5mg/325mg
more...

Acute, Short-Term Pain

<16 years: Safety and efficacy not established

≥16 years: 2 tabs PO q4-6hr PRN; not to exceed 8 tablets/day

Treatment duration: ≤5 days

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Interactions

Interaction Checker

tramadol/acetaminophen and

No Results

     
     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            1-10%

            Abdominal pain

            Anxiety

            Anorexia

            Asthenia

            Confusion

            Constipation

            Diarrhea

            Dizziness

            Dry mouth

            Dyspepsia

            Euphoria

            Fatigue

            Flatulence

            Headache

            Hot flushes

            Insomnia

            Nausea

            Nervousness

            Pruritus

            Rash

            Somnolence

            Sweating

            Tremor

            Vomiting

            <1%

            Abnormal hepatic function

            Abnormal thinking

            Abnormal vision

            Aggravated hypertension

            Aggravated migraine

            Albuminuria

            Amnesia

            Anemia

            Arrhythmia

            Ataxia

            Chest pain

            Convulsions

            Depersonalization

            Depression

            Drug abuse

            Dysphagia

            Dyspnea

            Emotional lability

            Hallucination

            Hypertension

            Hypertonia

            Hypotension

            Impotence

            Involuntary muscle contractions

            Melena

            Micturition disorder

            Migraine

            Oliguria

            Palpitation

            Paresthesias

            Paroniria

            Rigors

            Stupor

            Syncope

            Tachycardia

            Tinnitus

            Tongue edema

            Urinary retention

            Vertigo

            Weight decrease

            Withdrawal syndrome

            Frequency Not Defined

            Allergic reactions (including anaphylaxis and urticaria, Stevens-Johnson Syndrome/TENS)

            Cognitive dysfunction

            Depression

            Difficulty concentrating

            Gastrointestinal bleeding

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            Warnings

            Black Box Warnings

            Contains acetaminophen

            Hepatotoxicity may occur with acetaminophen doses that exceed 4 g/day; take into account all acetaminophen-containing products the patient is taking, including PRN doses and OTC products

            Acetaminophen associated with cases of acute liver failure, at times resulting in liver transplant and death

            New dosage limit allows no more than 325 mg/dosage unit for prescription medications that contain acetaminophen

            Healthcare professionals can direct patients to take 1 or 2 tablets, capsules, or other dosage units of a prescription product containing 325 mg of acetaminophen up to 6 times daily (12 dosage units) and still not exceed the maximum daily dose of acetaminophen (ie, 4000 mg/day)

            Contraindications

            Hypersensitivity

            Obstetric postoperative or post-delivery analgesia

            Acute intoxication with alcohol, narcotics, hypnotics, opioids, centrally-acting analgesics, or other psychotropic drugs

            Cautions

            Hepatitis liver failure

            Myocardial ischemia

            Orthostatic hypotension

            Pulmonary edema

            Suicidal tendency

            Vasodilation

            Risk of seizures

            As of January 2011, the FDA has mandated a dosage limit for all prescription medications that contain acetaminophen, allowing no more than 325 mg/dosage unit

            Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplantation or death; risk increases in individuals with underlying liver disease, alcohol ingestion, and/or use of more than 1 acetaminophen-containing product (see Black Box Warnings)

            Acetaminophen may cause rare serious skin reactions (eg, acute generalized exanthematous pustulosis, Stevens-Johnson Syndrome, toxic epidermal necrolysis), which can be fatal; discontinued at the first appearance of skin rash

            Serotonin syndrome (potentially life-threatening) may develop

            Off-label use in children

            • Severe respiratory depression reported with off-label use in children
            • Tramadol undergoes extensive hepatic metabolism; it is metabolized by CYP2D6 to the active metabolite O-desmethyltramadol (M1), which has a 200-fold greater affinity for opioid receptors than does tramadol
            • CYP2D6 poor metabolizers have shown a 20% increase in tramadol levels and a 40% decrease in O-desmethyltramadol (M1)
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            Pregnancy & Lactation

            Pregnancy category: C

            Lactation: Use caution

            Pregnancy Categories

            A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA:Information not available.

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            Pharmacology

            Mechanism of Action

            Tramadol: Nonopioid-derived synthetic opioid, centrally acting analgesic, but may act at least partially by binding to opioid mu receptors

            Acetaminophen: Acts on the hypothalamus to produce antipyresis and analgesia

            Absorption

            Bioavailability: 75%

            Peak plasma time: 2-3 hr

            Distribution

            VD: 2.6-2.9 L/kg

            Protein bound: 20%

            Metabolism

            Tramadol

            • Undergoes extensive hepatic metabolism; it is metabolized by CYP2D6 to the active metabolite O-desmethyltramadol (M1), which has a 200-fold greater affinity for opioid receptors than does tramadol
            • CYP2D6 poor metabolizers have shown a 20% increase in tramadol levels and a 40% decrease in O-desmethyltramadol (M1)

            Acetaminophen

            • Undergoes glucuronide and sulfate conjugation

            Elimination

            Half-life

            • Tramadol: 5-7 hr
            • Acetaminophen: 2-4 hr

            Excretion

            • Tramadol: Primarily renal excretion
            • Acetaminophen: Less than 9% excreted unchanged in urine

            Pharmacogenomics

            Genetic testing laboratories

            • The Roche Cytochrome AmpliChip P450 2D6/2C19 Genotyping and Phenotyping Assay can be used to identify 26 different alleles of CYP2D6
            • The following companies offer testing for CYP2D6 variants
            • DxS (http://www.dxsdiagnostics.com/)
            • Genelex (http://www.genelex.com)
            • LabCorp (http://www.labcorp.com/)
            • Luminex (http://www.luminexcorp.com)
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            Images

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            Formulary

            FormularyPatient Discounts

            To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

            Adding plans allows you to:

            • View the formulary and any restrictions for each plan.
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            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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